Therapeutic Drug Monitoring Market Outlook:
Therapeutic Drug Monitoring Market size was valued at USD 2.5 billion in 2024 and is projected to reach USD 4.9 billion by the end of 2037, rising at a CAGR of 6.1% during the forecast period, 2025 to2037. In 2025, the industry size of therapeutic drug monitoring is estimated at USD 2.6 billion.
The patient pool in the therapeutic drug monitoring market continues to expand due to the rise in global occurrence of chronic disease, including cancer, HIV, epilepsy, and organ failure. As per the report of the Centers for Disease Control and Prevention, nearly 6.5 million U.S. people suffer from epilepsy, and over 800,010 are affected with end-stage renal disease requiring immunosuppressants both requiring TDM. Further, the National Cancer Institute states that 2.4 million new cases of cancer diagnostics are registered annually in the U.S., with the leading area as oncology targeted for drug diagnostics. As of Q4 2024, the Producer Price Index (PPI) for clinical laboratory items, including TDM tests and diagnostic reagents, has risen 3.7% annually. On the other hand, indicating consistent increases in downstream service pricing without excessive consumer cost inflation, the Consumer Price Index (CPI) for medical care commodities, including diagnostic gadgets, increased 2.9% during the same time period.
The supply chain for the market of therapeutic drug monitoring relies on various interlinked components such as APIs, reagents, diagnostic assay kits, and device hardware. Various raw materials and the reagents are imported, as per the data from the U.S. Census Bureau Trade Data, reporting USD 1.5 billion in diagnostic reagents were imported by the U.S from Ireland, Germany, and Switzerland. Conversely, the U.S. is a net provider of lab automation tools and TDM-capable systems, with USD 1.7 billion in exports of high-end diagnostic instruments. Further, the market for chemical precursors is unstable worldwide, which has prompted near-shoring tactics, especially for expensive liquid chromatography supplies. Additionally, the U.S. and EU have enhanced their cross-border regulatory collaboration on harmonizing shipping norms for TDM reagents.
